New heart valve for failing mitral valve
Part of Heart & circulation clinical trials.
This trial tests a new, less invasive heart valve (called SAPIEN X4) placed through a vein in your leg to replace a failing mitral valve that was previously repaired or replaced. It is for people who are at high risk for open-heart surgery and have a leaky or narrowed mitral valve.
Summary written for real people, not researchers, by Clin2.
Who can take part
- You have a mitral valve (the valve between the heart's left chambers) that is failing—either a previously replaced valve or your own valve with a ring from past surgery—and it is now narrowed or leaking at least moderately.
- Your heart care team has determined you are at high risk for open-heart surgery.
- You are experiencing symptoms like shortness of breath or fatigue with everyday activities (NYHA class II or more).
- You are able to have the valve replacement done through a vein in your leg (femoral access).
- You do not have other serious heart valve problems, severe right heart weakness, or a recent heart attack or stroke.
Quick eligibility check
Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.
Similar studies
Other trials that look related to this one.
This trial studies a minimally invasive mitral valve repair/replacement approach for people with severe mitral regurgitation (leaky mitral valve) who are not good candidates for standard surgery or catheter options. It may help improve symptoms by treating the leaky valve when other treatments aren’t suitable.
This trial tests a new, less invasive heart valve (Sutra Hemi-valve) for people with a leaky mitral valve who cannot have standard surgery. The valve is delivered through a vein in your leg, so you avoid open-heart surgery.
This trial studies a catheter-based procedure to replace the mitral valve in people with severe (or specific moderate) mitral valve leakage that causes symptoms. It may help by reducing leaking and related symptoms when standard surgery or less invasive fixes aren’t suitable for you.
This study tests a new catheter-based system to treat severe mitral valve leaking when open-heart surgery is considered high risk. It may help improve blood flow and symptoms by repairing the valve without open surgery, using ultrasound guidance and follow-up visits to track safety and results.
This trial studies whether a new transcatheter aortic valve (SAPIEN X4) is safe and works well in people whose previously implanted aortic valve is now failing. It may help reduce valve symptoms in higher-surgery-risk patients who are not good candidates for open-heart valve replacement.
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